Vascular closure with multiple connections

ABSTRACT

Among other things, methods and apparatus for inserting devices for closing a tissue opening are disclosed. An anchoring or sealing member has one or more stems and/or filaments that are offset from the center of the member, so that lateral adjustments or movements of the anchoring or sealing member do not uncover the opening, cause the anchoring or sealing member to stick through or pull through the opening. Embodiments including a valve adapted to accommodate a guide wire for addressing emergencies are also disclosed.

This application claims the benefit of U.S. Provisional Application Ser.No. 61/716,155 (filed on Oct. 19, 2012), which is incorporated herein byreference in its entirety.

The present disclosure concerns closures for openings in bodily tissue.In particular, the disclosure concerns devices for closing relativelylarge holes in vessels, organs or other locations.

BACKGROUND

In medical procedures involving internal access to blood vessels, it isnecessary once the procedure is concluded to prevent substantialbleeding through the opening created and/or maintained by a device (e.g.sheath or introducer) to access the blood vessel interior. Externalpressure applied via the skin to the vessel has been a primary way toclose or minimize the hole so that natural clotting and repair canoccur. However, applying such pressure following removal of the accessdevice can result in significant blood loss, is difficult for aphysician, nurse or other professional to apply, and can result inminimizing or stopping flow in the vessel, which over time can havenegative consequences.

Closures for holes in vascular walls have been proposed that includeplugs, seals or other blocking pieces placed in or over the hole. Anumber of structures and techniques have been proposed for placing andholding such closures, so that minimal amounts of blood escape thevessel. It has been found, however, that such closures can be lessefficacious in sealing vascular or other tissue holes that arerelatively large. While such closures may work well in closing holesmade by small introducers, as for example those used to introduce smallcatheters for infusion of contrast agents or medicaments, they may notbe able to be easily or efficiently placed to close larger openings, asfor example those made by introducers for intra-aortic balloon (IAB)pump or abdominal aortic aneurysm (AAA) repair. Existing closures may bepoorly centered over a hole, allowing a portion of the hole to beuncovered, or a portion of the closure may bend due to blood flow,creating a gap between the closure and the vessel tissue. In such cases,leakage of blood and resultant complications can occur.

Likewise, other types of relatively large tissue openings (e.g. patentforamen ovale (PFO), fistulae, or the like) present difficulties forclosure by existing devices. Accordingly, there is a need forimprovement in this area.

SUMMARY

Among other things, there are disclosed medical treatment devices for atissue opening in a patient. Particular embodiments of such devicesinclude an anchoring member adapted for engagement with tissue borderingthe tissue opening, and at least first and second filaments connected tothe anchoring member and adapted to extend from the anchoring member toa position outside of the patient, so that pulling one or more of thefilaments tends to engage or press the anchoring member against thetissue. The anchoring member has a center point inside at least oneedge, with the connection of the first filament and the anchoring memberbeing offset laterally in a first direction from the center point, andthe connection of the second filament and the anchoring member offsetlaterally in a second direction from the center point. The first andsecond directions may be substantially opposed to each other, and thedistance between the first and second filaments may be less than orequal to a dimension of the tissue opening.

As particular examples, the anchoring member includes at least first andsecond stems monolithic with the remainder of the anchoring member, withthe first filament is attached to the first stem and the second filamentis attached to the second stem. The anchoring member may have a majoraxis through the center point and extending between first and secondends of the anchoring member, and the first and second stems are on thatmajor axis. The first and second stems can be equidistant from thecenter point. Embodiments in which the anchoring member includes atleast three, four or more stems, each having a respective filament, eachdisplaced from the center point by approximately the same distance, andeach separated from adjacent stems by approximately the same distanceand/or angle are also contemplated. Certain embodiments of the anchoringmember include a hemostatic valve adapted to permit passage of a guidewire therethrough, the valve substantially preventing blood flow throughthe anchoring member. The valve may be placed substantially at thecenter point of the anchoring member or its wall, and be offset fromeach of said first and second filaments. A guide wire may be providedthat extends through the valve.

In particular embodiments, including embodiments in which an anchoringor sealing member has a single stem or filament, a system or apparatusmay include a pusher with a lumen. The pusher is configured to move overthe stem with at least a portion of the stem within the lumen, and has aforward portion that is inwardly tapered. In embodiments in which afilament is connected with the stem, a pusher can be provided with alumen and configured to move over the stem and filament with at least aportion of the stem and at least portion of the filament within thelumen. An indicator is fixed with respect to at least one of the stemand filament and at least partially within the pusher, the indicatorhaving at least a portion contrasting with the pusher. The indicator ispositioned to exit from the pusher as the pusher is moved along at leastone of the stem and the filament so that the contrasting portion exitsfrom the pusher at a point at which the pusher has moved a desireddistance, such as a distance necessary to lock the anchoring or sealingmember in place against tissue.

Other examples of medical treatment devices for a tissue opening in apatient include an anchoring member adapted for engagement with tissuebordering the tissue opening, the anchoring member including a wall, thewall having a valve portion allowing penetration through the wall andproviding hemostatic control. A guide wire is inserted through the valveso that a portion of the guide wire is on either side of the wall,wherein when the anchoring member is engaged with tissue bordering thetissue opening, a portion of the guide wire extends through the opening.Such an anchoring member can include at least one stem monolithic withthe wall and offset from the valve, e.g. at least first and second stemsjoined to the wall and offset from the valve, wherein the first andsecond stems and the valve are along a line. In such embodiments, afirst distance between the first stem and the valve and a seconddistance between the second stem and the valve may be substantially thesame, and/or the distance between the first and second stems may beequal to or less than a dimension of the tissue opening. A firstfilament can be connected to the first stem and a second filamentconnected to the second stem, or at least one filament connected to theanchoring member and offset from the valve.

Methods for treating an opening in tissue are also disclosed, and inparticular embodiments include inserting through the opening a medicaltreatment device having an anchoring member and at least first andsecond filaments connected to the anchoring member and adapted to extendfrom the anchoring member to a position outside of the patient. Theanchoring member has a center point, with the connection of the firstfilament and the anchoring member offset laterally in a first directionfrom the center point, and the connection of the second filament and theanchoring member offset laterally in a second direction from the centerpoint, with the first and second directions substantially opposed toeach other, so that the first and second filament extend to a locationoutside the patient. The user provides tension on the first and secondfilaments so that the anchoring member is firmly engaged with tissueadjacent the opening, one or more of the anchoring member and thefilaments preventing movement of the anchoring member with respect tothe opening to the degree that an end of the anchoring member is withinthe hole. The anchoring member is locked in place with respect to thetissue. Methods can also include, with the anchoring member having firstand second stems and the first filament is attached to the first stemand the second filament is attached to the second stem, an insertingstep that includes placing the anchoring member so that the first andsecond stems both extend through the hole so that the stems limitmovement of the anchoring member with respect to the hole. With theanchoring member having a hemostatic valve and a guide wire extendingthrough the valve, methods can include monitoring the treatment of thetissue opening, and where an emergency is detected, applying a medicaldevice over the guide wire to one or both of the tissue and the hole.

Devices and methods as described herein provide solutions to problemsexisting with some types of vascular closure devices, including risks ofimproper placement of the device so that an opening is not closed orcovered sufficiently, and of damage or eversion of a closure whentension is applied. The multiple connections of the disclosuredistribute pulling force through the connections, making it less likelyfor any particular connection to fail, or for too much force at onepoint to cause an eversion or pull-through of a closure device. Further,in cases where failure of the treatment occurs, emergency measures mustbe taken, and structure to facilitate such measures is also disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an embodiment of a device or part of asystem for closing bodily openings.

FIG. 1A is a perspective view of an embodiment of a device or part of asystem for closing bodily openings.

FIG. 2 is a side view of the embodiment of FIG. 1.

FIG. 3 is a top view of the embodiment of FIG. 1.

FIG. 4 is a side view of a portion of an embodiment similar to that ofFIG. 1 showing an embodiment of an elongated member formed as a stem.

FIG. 5 is a perspective view of an embodiment of a device or part of asystem for closing bodily openings.

FIG. 6 is a perspective view of an embodiment similar to that of FIG. 5with a different example of buffer configuration.

FIG. 7 is a perspective view of an embodiment as in FIG. 1 includingadditional features.

FIG. 7A is a side view of an embodiment of a valve or seal configurationusable in the disclosed embodiments.

FIGS. 7B-D are a top view (FIG. 7B) and part cross-sectional viewsperpendicular to a slit (FIGS. 7C-D) of an embodiment of a valve or sealconfiguration usable in the disclosed embodiments.

FIGS. 7E-F are side views of an embodiment of a valve or sealconfiguration usable in the disclosed embodiments.

FIGS. 7G-7H are part cross-sectional views of embodiments of valve orseal configurations and connections usable in the disclosed embodiments.

FIG. 8 is a top view of the embodiment of FIG. 7.

FIG. 9 is a perspective view of an embodiment similar to that of FIG. 5with features shown in FIG. 7.

FIG. 10 is a perspective view of an embodiment as in FIG. 1 withadditional features.

FIG. 11 is a perspective view of an embodiment of a device or part of asystem for closing bodily openings.

FIG. 12 is a part-sectional view of the embodiment of FIG. 11.

FIGS. 13A-B are side views of an embodiment of at least part of aclosure system.

FIG. 13C is a part cross-sectional view of the embodiment of FIGS. 13A-B.

DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

To promote an understanding of the principles of the disclosure,reference will now be made to certain embodiments and specific languagewill be used to describe the same. It will nevertheless be understoodthat no limitation of the scope of the claims is thereby intended, suchalterations and further modifications of the disclosed methods and/ordevices, and such further applications of the principles of thedisclosure as described herein, being contemplated as would normallyoccur to one skilled in the art to which the disclosure relates.

Referring now generally to FIG. 1, there is shown an embodiment of aclosure device 20 for use itself or with a system for closing holes intissue, such as those formed in the walls of blood vessels duringcatheterizations or other treatments, or septal defects (e.g. patentforamen ovale, or PFO). Embodiments of device 20 can be used for closingholes of any size, whether relatively small or relatively large.However, device 20 is believed to be effective in closing large orelongated holes, where existing devices are not or present difficultiesor uncertainties in closing such holes.

Device 20 includes an internal anchoring or sealing member 22 that isplaced on one side of a hole to be closed (e.g. within a blood vessel)and at least two elongated members (e.g. members 24, 26 in FIGS. 1-3)extending proximally from anchoring member 22. As will be discussedfurther below, elongated members 24, 26 may be stems that are part of orare fixed to anchoring member 22, or may be threads or other types offilaments attached to anchoring member 22.

Anchoring or sealing member 22 in the illustrated embodiment is in theillustrated embodiment is a curved toggle or dome having a wall 30. Wall30 can have a constant or varying thickness, for example in certainembodiments having a maximum thickness in the range of about 0.0050inches to about 0.050 inches, and in a particular embodiment about 0.015inches. In the illustrated embodiment, the maximum thickness of member22 is at and/or between the connection(s) with elongated members 24 and26 are, and the thickness decreases uniformly out to a rim 32. Anchoringor sealing member 22 is part-spheroidal in an unstressed state (e.g.FIGS. 1-3), having a substantially oval-shaped (e.g. elliptical) rim 32.Rim 32 is substantially in one plane in this embodiment, having littleor no breadth. Member 22 has an exterior convex surface 34 and aninterior concave surface 36 which is open and unobstructed. Inparticular embodiments, surfaces 34 and 36 may have substantially thesame radii, so that the overall thickness of wall 30 is substantiallyconstant, or may have differing radii, so that they intersect orapproach each other at (and wall 32 thins toward) rim 32. A center point38 may have a tangent plane that is parallel to the plane of rim 32. Anelongated toggle or dome member 22 has respective ends or end portions39 along a major axis MA, so that the distance between ends 39 is thelargest dimension of member 22.

FIG. 1A shows an example of an anchoring member 22 that is essentiallythe same as member 22 in FIGS. 1-3, with the exception that thegenerally elliptical form of the embodiment in FIGS. 1-3 is truncatedsubstantially along the major axis MA, leaving an anchoring member inthe form of a toggle. Rim 32 around end portions 39 may thus form partof an ellipse. Exterior convex surface 34, interior concave surface 36and center point 38 as described above may be seen in this example.

In embodiments in which anchoring member 22 is flexible, suchflexibility permits an elastic or inelastic deformation or change inshape. Under stress, as discussed further below, internal anchoring orsealing member 22 can be folded for placement in a delivery device, andduring or after placement can open or flatten from the folded conditionto move close or closer to tissue. Member 22 can be constructed so as tocompletely flatten (e.g. surface 36 substantially conforming tosurrounding tissue) under stress as experienced after implantation, orso as to not completely flatten under such stress (e.g. maintaining anat least slightly concave surface 36 or arch) in use, as discussedfurther below.

The illustrated embodiment of anchoring or sealing member 22 is made ofa flexible material that is biocompatible and resorbable in particularembodiments. In certain embodiments a flexible material is used that iselastically foldable, i.e. that can be folded or compressed into a tubeor other holder, and will resume the original dome-like shape once movedout of the holder. Specific examples of materials that have been foundto be particularly useful are mixtures of polycaprolactone and L-lactideas disclosed in Application Ser. No. 61/716,182, filed on Oct. 19, 2012,which is incorporated by reference herein in its entirety.

As noted previously, examples of elongated members 24 include filamentsand/or stems attached to member 22. For embodiments in which elongatedmembers 24 are or include stems, an exemplary stem 40 is shown in FIG.4, which is unitary (i.e. monolithic) with or joined to surface 36 orother part of member 22. As discussed further below, additional stemsmay be provided on member 22 in other embodiments. Each stem 40 in thisembodiment is configured to attach to a suture, thread or other filament41, and in the example of FIG. 4 stems 40 each include an eyelet 42through which such a filament 41 is threaded. Stems 40 further includeprotrusions or beads 44 at particular intervals between eyelet 42 andsurface 36, and preferably between eyelet 42 and a plane in which rim 32of member 22 is located. Stems 40 have thickened bases 46 in particularembodiments. In the embodiment of FIG. 4, for example, a base 46 of astem 40 is conical or outwardly flared from stem 40 toward surface 36.The widened base 46 provides a sturdier or more secure connectionbetween stem 40 and the rest of member 22, which may be needed withgreater strains associated with larger vascular or other openings to beclosed. A conical or flared base 46 can also provide a non-edged andlarger surface against which tissue surrounding the hole can abut. Thebases 46 can be lodged against the tissue surrounding the hole, ensuringthe positioning of member 22 across the hole while spreading out stresson the tissue.

Elongated members 24, 26 are substantially identical to each other inthe illustrated embodiments, e.g. each of elongated members 24, 26 as astem (e.g. stem 40) to which a suture or other type of filament or fiberis attached. Filament 41 extends proximally from stem 40 (and/or fromsurface 36 of member 22, e.g. if elongated members 24, 26 are connecteddirectly to surface 36) a distance that is at least sufficient tostretch from an implanted location of member 22 (e.g. within a vessel)to a location outside the patient's body. As indicated above, filament41 may be directly connected to stem 40, as by threading or loopingthrough eyelet 42 so that filament 41 doubles up on itself, or by fixingfilament 41 directly to stem 40 as by welding, gluing, or the like.

The embodiment of FIG. 1 shows an elongated internal anchoring orsealing member 22, substantially in an oval or elliptical shape whenviewed from top or bottom (e.g. FIG. 3). Elongated members 24, 26 (e.g.stem 40) are on opposite sides of the center point 38 of sealing member22. For example, in the embodiment of FIGS. 1-3 in which sealing member22 is substantially elliptical and has a major axis MA, elongatedmembers 24 are joined to sealing member 22 so that they intersect majoraxis MA. In a particular case, elongated members 24 are located at orintersecting the foci of the ellipse. In other cases, elongated members24 may each be located approximately halfway between the center 38 and arespective end 39 of sealing member 22. As indicated, sealing member 22is intended to be larger in size or outermost extent than an opening ina vessel or other body part to be closed. Particular embodiments ofsealing member 22 will have respective elongated members 24, 26separated by a distance that is less than or approximately equal to thediameter of an introducer used for access to a vessel, and thus lessthan or approximately equal to the diameter of the opening in the vesselto be closed by member 22.

As noted above, embodiments of anchoring or sealing members 22 havingmore than two elongated members 24, 26 are contemplated. The embodimentsof FIGS. 5, 6, and 9, for example, show a sealing member 22 with fourelongated members 24 attached to it, each offset from the center 38 andfrom the major axis MA. That embodiment shows the placement of elongatedmembers 24 is such that an adjacent pair of elongated members 24 (e.g.toward the top or bottom in FIG. 9) is on a line substantially parallelto axis MA, an adjacent pair of elongated members 24 (e.g. to the rightor left in FIG. 9) is on a line substantially perpendicular to axis MA.Opposing or diagonal pairs of elongated members 24 are on lines throughcenter 38 in the illustrated embodiment. Such embodiments space out theapplication of force through elongated members 24 to sealing member 22,resulting in better attachment of the entirety of sealing member 22 tothe inside of the vessel or to other tissue when tension is applied toelongated members 24.

One or more portions of buffer material 60 are included in theembodiments shown in FIGS. 5-6. Such buffers 60 are made ofbiocompatible material, and preferably resorbable material. Inparticular embodiments, buffers 60 are of small intestinal submucosa(SIS) material. Referring to FIG. 5, buffer 60 is a single sheet orlayer with multiple holes 62 positioned in locations compatible withloading buffer 60 onto elongated members 24 of an anchoring or sealingmember 22. One or more locking members 70 with central holes 72 areprovided to slide over elongated members 24 to lock buffer 60 into placewith respect to anchoring or sealing member 22, and member 22 withrespect to the hole in tissue. Referring to FIG. 6, a plurality ofbuffer pieces 60, in the form of flat discs or plates in the illustratedembodiment, are provided. As seen in that figure, one buffer piece 60can be provided for each stem 40, with a specific locking member 70 foreach elongated member 24. It will be understood that in otherembodiments multiple buffer pieces 60 may be provided to one or moreelongated members 24, and that no buffer piece 60 may be provided to oneor more elongated members 24. In particular embodiments, the width ordiameter of buffer pieces 60 may be chosen so that portions of two ormore such pieces 60 overlap when they are placed along their respectiveelongated members 24 (see e.g. FIG. 6). Locking members 70, inparticular embodiments, are sized and/or configured so that they do notoverlap when placed on respective elongated members 24. For example,where stems 40 are separated by a specific distance, the radius of anexemplary locking member 70 may be half or less of that specificdistance. In other embodiments, a single locking member 70 may beprovided with multiple holes 72 positioned so that the single lockingmember 70 can be used with multiple elongated members 24.

Embodiments of anchoring or sealing member 22, shown in examples inFIGS. 7-9, may also include an opening 80 for passage of a guide wire82. The illustrated embodiment shows opening 80 in the center 38(unmarked in FIGS. 7-9 to maintain clarity) of member 22. In otherrespects, this embodiment of member 22 is essentially the same asembodiments described above, with elongated members 24 (e.g. stems 40)offset from the center. Hole 80 in this embodiment is occupied by orincludes a valve or seal 84 configured for hemostatic control both whenguide wire 82 is inserted through it and when no guide wire is present.Exemplary valves or seals may include an opening through member 22having at least a portion with a diameter less than the diameter of aguide wire to be extended through it, so that member 22 engages the wirewith some force. Such a hole may be cylindrical (e.g. FIG. 7A), a“duck-bill” configuration (e.g. FIGS. 7B-D), conical (e.g. FIG. 7H, withthe smallest diameter on the concave exterior of member 22), orotherwise configured. A “duck-bill” configuration includes two leaves 81a pressed against each other at a slit 81 b, with the leaves generallypointed or oriented toward an outer or exterior surface of member 22. Aguide wire 82 through slit 81 b is engaged by leaves 81 a, and when wire82 is removed, the leaves press the slit closed to limit or eliminateleakage. A conical opening configuration as indicated in FIG. 7E pinchestogether as member 22 is pulled against the vascular wall, to limit oreliminate leakage through the opening. Another example of a suitablevalve or seal would be an opening with opposed interdigitating (i.e.overlapping) flanges or fingers (e.g. FIG. 7E-F). Wire 82 insertedthrough the hole bends the flanges or fingers, with the flanges orfingers pressed against the wire to maintain a seal. When wire 82 iswithdrawn, the overlapping nature of the flanges or fingers prevents orlimits flow through the hole. In other embodiments, a stem 24 and/or 26may have guides 85 attached to allow passage of wire 82 close to andalong the stem (e.g. FIG. 7G). Further, it will be understood that acenter opening for passage of wire 82 through member 22 may be adjacentor under a stem (e.g. FIG. 7G), whether the stem is at or offset fromthe center of member 22, and that an opening for a wire 82 may be offsetfrom the center of member 22. The opening for wire 82 may have a wallthicker than that of member 22 (e.g. FIG. 7H).

It has been noted that, with the sizes of vascular holes for whichmember 22 is intended, there is the potential for substantial or massiveblood loss if the member 22 or another part of device 20 is improperlyplaced or otherwise does not operate as intended. Guide wire 82 is notused for placement of anchoring or sealing member 22 in someembodiments, but merely accompanies member 22 as it is placed, toprovide a safety measure in maintaining vessel access in case of anemergency. That is, should there be a breakage or improper placement ofmember 22 or another part of device 20 or other emergency, guide wire 82extends through member 22 and into the vessel, and permits insertion ofan emergency sheath, valve, plug or other device to address thesituation. While FIGS. 7 and 8 show an embodiment with two elongatedmembers 24, similar to the embodiment in FIGS. 1-3, FIG. 9 shows anembodiment with four elongated members 24, similar to the embodimentsshown in FIGS. 5-6. It will be understood that wire and valve usage asnoted above can be incorporated into members 22 with a single elongatedmember 24 placed in the center of member 22.

In addition to a force-spreading characteristic of the multipleelongated members 24, their use in connection with distance between themprovides a better opportunity for ensuring proper placement or centeringof anchoring or sealing member 22 with respect to a tissue hole. Themultiple filament and/or stem embodiments do not permit member 22 to beplaced in or to slide to a position in which the hole is not covered, orin which an end 39 of member 22 is in or positioned through the hole.Rather, the presence of spread-apart multiple stems or filaments thatextend through the hole means that position or movement of member 22relative to the hole is limited. The member 22 is less likely to bemispositioned, because of interference between the tissue surroundingthe hole and the stems or filaments.

Insertion of embodiments of sealing or anchoring member 22 can beaccomplished using devices (e.g. cannulas, catheters, or the like) knownfor providing access to bodily openings in blood vessels, organs orother tissues. Device 20 is inserted through the opening to be closed,and is retracted so that at least a portion of rim 32 and perhaps atleast a portion of inner surface 36 engages tissue. The multipleelongated members 24 help to ensure proper positioning of device 20,i.e. with a portion of member 22 on opposing sides of the hole orsurrounding the hole, so that member 22 firmly engages tissue and doesnot slip back through the hole. That is, elongated members 24 preventshifting of member 22 into an unacceptable position relative to the holedue to interference with the sides of the hole. Once the member 22 ispositioned, buffer 60 may be moved along elongated members 24 by orprior to locking members 70. With locking members 70 engaging elongatedmembers 24 and holding buffer 60 and member 22 over the hole and/orengaging tissue around the hole, the hole is closed. Filaments 41extending from elongated members 24 (or elongated members 24 themselvesif they are filaments) are cut and pulled out of the patient, and thepathway through the skin used to access the bodily opening is closed.

FIG. 10 depicts an example of an internal anchoring or sealing member 22similar to that shown in FIGS. 1-3, and common elements described abovewith respect to FIGS. 1-3 will not be repeated here. In this embodiment,a respective base member 90 is joined to or part of each elongatedmember 24 and joined to or part of inner surface 36 of member 22. Itwill be understood that less than all of the elongated members 24 mayhave such a base member 90 in other embodiments. In the particularexample, base members 90 are solid parts that are curved substantiallyalong the curvature of surface 36, e.g. forming a part of an ellipseconcentric with an elliptical rim 32 of member 22. Such base members cannot only reinforce the connection between elongated members 24 and wall30 of member 22, but can also help to better index the elongated members24 within the bodily opening during deployment. The illustrated exampleof base members 90, which are rounded or part elliptical, can help indexwith respect to the bodily opening by lying adjacent or engaging a rimof the opening. That is, a side surface of members 90 generally facingrim 32 of member 22 can engage or face the sides of the tissue opening.The sides of members 90 can provide a larger surface to help preventmigration of member 22 or provide some frictional securing of member 22within the tissue opening.

FIGS. 11 and 12 show an example of an embodiment of device 20 in whichelongated members 24 are not fixed with respect to anchoring or sealingmember 22. In that example, member 22 is similar to that described withrespect to FIGS. 1-3, e.g. wall 30 and other parts excepting elongatedmembers 24 and the presence of holes 94. In this embodiment, holes 94are placed at or near the foci of an elliptical or ellipsoidal member22. Elongated members 24 in the embodiment of FIGS. 11-12 may be a stemor filament as described above, with a dome-like seal 96 at a distalend. Each seal 96 is sized and configured to cover a respective hole 94,and may be formed as a smaller and/or circular version of member 22described above. Pulling on one or both of elongated members 24 move therespective seal(s) 96 to and/or over respective holes 94, to preventleakage through holes 94 and/or to move member 22 against tissue tocover all or part of a bodily opening.

FIGS. 13A-C show an embodiment of at least part of a closure systemhaving an internal or distal sealing or anchoring member 222, from whicha stem 224 with an eyelet 241 and a filament 226 through eyelet 241extend proximally. Along stem 224 and/or filament 226 are a holding disc270, a sheet or other mass of buffer material 260 (e.g. small intestinesubmucosa, or SIS), and a locking disc 271. A pusher 230 is provided tomove along filament 226 and/or stem 224 to move at least disc 271 andbuffer material 260 along stem 224 and/or filament 226, to lock thesystem (e.g. with buffer 260 pressed between discs 270 and 271, and aportion of a vessel V or other tissue between disc 270 and member 222).This embodiment may be or include features as disclosed above (e.g.multiple elongated stems, filaments or other members) or as disclosed inapplication Ser. No. 13/111,338 (filed on May 19, 2011) and Ser. No.13/303,707 (filed on Nov. 23, 2011), incorporated herein by reference intheir entireties.

Embodiments of a pusher device having a substantially cylindrical outerform, with a central lumen to allow the pusher device to slide along andover at least a part of a filament and/or stem connected to a member 22have been tried. In testing, it was found that such a cylindrical pusheroperated well so long as tissue planes intersecting the wound or channelthrough the skin were generally oriented so that the wound or channelwas itself substantially cylindrical. In other cases, such a cylindricalpusher device could catch on or be impeded by the tissue planes.

To resolve that issue, pusher device 230 is substantiallytorpedo-shaped, having a rearward gripping or base portion 232 and aforward pushing portion 234. Base portion 232 has a substantiallycylindrical outer surface 236 in this embodiment, with a rearward orproximal end 238 that is rounded. The illustrated embodiment of forwardportion 234 has an outer surface 240 that transitions smoothly withsurface 236 of gripping portion 232, and tapers inward toward forwardend 242. In particular embodiments, the tapering outer surface 240describes a portion of a regular circular cone (i.e. a plane tangent tosurface 240 intersects surface 240 in a line) or a convex solid (e.g. aplane tangent to surface 240 intersects surface 240 in a point, or aplane including the longitudinal axis of pusher 230 intersects surface240 in a curve such as a parabola). Pusher 230 has a linear lumen 246extending between ends 238 and 242. Lumen 246 may have a substantiallyconstant diameter between ends 238 and 242, and in such cases thethickness of the wall of pusher 230 (i.e. the material between lumen 246and outer surfaces 236, 240) decreases in tapering forward portion 234as one approaches end 242. In other embodiments, lumen 246 may decreasein diameter in forward portion 234, so that the wall has a smaller or nodecrease in width. However, in such cases the diameter of lumen 246remains large enough to accommodate the filament and/or stem parts overwhich it is to pass in locking the closure device. End 242 may berounded in particular embodiments.

Pusher 230 or other parts of the system in particular embodiments canalso provide the user an indication as to when locking disc 271 and/orother items are in a desired placement and he or she can thus stoppushing. For example, in the embodiment of FIGS. 13A-C an indicator 250is placed within lumen 246 of pusher 230. Indicator 250 is fixed to oneor both of filament 226 and stem 224 connected to anchor or closuremember 22, and in the illustrated embodiment is fixed to filament 226.Pusher 230 is movable with respect to filament 226 and stem 224, and isthus also movable with respect to indicator 250. Indicator 250 in theillustrated embodiment is a tube having a proximal portion 252 and aforward or distal portion 254. In other embodiments, indicator 250 maybe a sheet, wrap (e.g. a shrink-wrap plastic film), or other attachment.

At least a portion of indicator 250 has a contrasting surface or portion256 differentiating it from proximal end 238 or more of base portion 232of pusher 230, as by contrasting coloration, lineation, writing,texture, or other observable features. The illustrated embodiment ofindicator 250 includes contrasting portion 256 at or toward distalportion 254, so that use of pusher uncovers a substantial portion ofindicator 250 before contrasting portion 256 is exposed from pusher 230.It will be understood that in other embodiments all of indicator 250, orat least a part of proximal portion 252, may be included in contrastingportion 256, so that the contrasting portion 256 is observable as soonas any part of indicator 250 exits from pusher 230. The length andpositioning of indicator 250, or the ratio or other relationship of itslength with that of pusher 230, are chosen so that when end 242 ofpusher 230 is in a position as indicated in FIG. 13C, having pushed disc271 and buffer 260 against disc 270 and/or tissue, so that the system islocked with respect to member 222 and its filament 226 and/or stem 224,at least a portion of the contrasting part 256 is exposed from theproximal end 238 of pusher 230, observable to the user. Thus, when theuser sees contrasting part 256, or a specified amount of part 256, he orshe knows that the system is locked as intended. The user is accordinglynot limited to relying on resistance felt through the pusher todetermine when the locking disc and other items are fully deployed (e.g.snug against the vessel or other tissue against which the anchoring orsealing member 222 was engaged).

To summarize, as noted above anchoring or sealing member 222 is engagedto the inside of a blood vessel or other tissue portion adjacent a holeto be closed. Stem 224, filament 226, and discs 270, 271 and buffer 260along stem 224 and/or filament 226, extend proximally into or through anopening in the skin to the hole. Pusher 230 is moved forward alongfilament 226 and stem 224 (in the illustrated embodiment) to forcelocking disc 271, buffer material 260, holding disc 279 (if needed),and/or other parts forward. As pusher 230 moves forward, its pushing end242 engages disc 271 to push it and the noted parts along filament 226and/or stem 224. Indicator 250 remains fixed to filament 226 and/or stem224, and so pusher 230 moves over indicator 250 as well, so thateventually proximal portion 252 of indicator 250 is exposed (or furtherexposed) from the proximal end 238 of pusher 230 as pusher 230 is movedforward. When the user sees contrasting part 256 emerge from pusher 230,whether part 256 is at the end of indicator 250 or a distance from theend, it is known that end 242 of pusher 230 has pushed locking disc 271,buffer 260 and any other items into a fully-deployed state, so thatmember 222 is locked in place and the hole is covered or sealed.

As pusher 230 is used as indicated, end 212 and tapering outer surface210 lead within the opening in the skin. The taper of surface 210 allowspusher 230 to move through the skin opening with less likelihood ofcatching or snagging on tissue plane(s) adjoining the opening. Rather,tapering outer surface 210, to the extent necessary, provides a smoothadjustment of tissue plane(s) and/or dilation of the opening throughthem.

While description of particular embodiments (e.g. multiple connectionsfor anchoring or sealing members) has been made above, it will beunderstood that other embodiments (such as single connections and othertypes of anchoring or sealing members) can be used. For example,features similar or related to those shown in this disclosure are alsoshown and described in commonly-owned application Ser. No. 13/111,338(filed on May 19, 2011) and Ser. No. 13/303,707 (filed on Nov. 23,2011), which are incorporated herein by reference in their entireties,and such features can be used with or in place of features disclosedherein.

While the disclosure has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the most preferred embodiments have been shown and described, andthat all changes and modifications that come within the spirit of thedisclosure are desired to be protected. For example, elongated members24 may be placed in alternative configurations with respect to the restof member 22, such as having two elongated members 24 adjacent ends 39and on major axis MA, and two elongated members 24 offset from majoraxis MA so that a line between them is through center 38 andsubstantially perpendicular to axis MA. Further, features or aspectsdiscussed in connection or in the context of one embodiment or part maybe used with or incorporated into other embodiments, parts or aspects ofthis disclosure. In addition, all publications cited herein areindicative of the abilities of those of ordinary skill in the art andare hereby incorporated by reference in their entirety as ifindividually incorporated by reference and fully set forth.

What is claimed is:
 1. A medical treatment device for a tissue openingin a patient, comprising: an anchoring member adapted for engagementwith tissue bordering the tissue opening, the anchoring member having aconcave inner surface and a convex outer surface; and at least first andsecond filaments connected to the anchoring member and adapted to extendfrom the anchoring member to a position outside of the patient so thatpulling one or more of the filaments tends to engage or press theanchoring member against the tissue to seal the tissue opening, whereinthe anchoring member has a center point inside at least one edge, theanchoring member includes at least first and second stems positionedinside the at least one edge, the first stem having a first endadjoining the inner surface of the anchoring member at a first point andextending away from the inner surface to a free second end, said secondstem having a third end adjoining the inner surface of the anchoringmember at a second point an extending away from the inner surface to afree fourth end, the first and second stem being separate from eachother and wherein the first stem is offset laterally in a firstdirection from the center point, and the second stem is offset laterallyin a second direction from the center point, the first and seconddirection substantially opposed to each other, wherein the distancebetween the first and second stems is less than or equal to a dimensionof the tissue opening, and wherein the first filament is attached to thefirst stem and the second filament is attached to the second stem. 2.The apparatus of claim 1, wherein the at least first and second stemsare monolithic with the remainder of the anchoring member, wherein thefirst filament is threadedly attached to the first stem and the secondfilament is threadedly attached to the second stem.
 3. The apparatus ofclaim 2, wherein the anchoring member has a major axis through thecenter point and extending between first and second ends of theanchoring member, and wherein the first and second stems are on themajor axis.
 4. The apparatus of claim 3, wherein the first and secondstems are equidistant from the center point.
 5. The apparatus of claim1, wherein the anchoring member includes at least third and fourthstems, each of the at least third and fourth stems having a respectivefilament, each of said stems displaced from the center point byapproximately the same distance, and each of the stems separated fromadjacent stems by approximately the same angle.
 6. The apparatus ofclaim 1, wherein the anchoring member includes a hemostatic valveadapted to permit passage of a guidewire therethrough, the valvesubstantially preventing blood flow from the convex outer surface to theconcave inner surface of the anchoring member.
 7. The apparatus of claim6, wherein the valve is substantially at the center point.
 8. Theapparatus of claim 6, wherein the valve is offset from each of saidfirst and second filaments.
 9. The apparatus of claim 6, furthercomprising a guidewire extending through the valve.
 10. A method oftreating an opening in tissue, comprising: inserting through the openinga medical treatment device having an anchoring member having a concaveinner surface configured to cover all of the opening, the medicaltreatment device having at least first and second filaments connected tothe anchoring member and adapted to extend from the anchoring member toa position outside of the patient, the first filament having a first endadjoining the inner surface of the anchoring member at a first point andextending away from the inner surface to a free second end, said secondfilament having a third end adjoining the inner surface of the anchoringmember at a second point and extending away from the inner surface to afree fourth end, the first and second filament being separate from eachother, the anchoring member having a center point, with the first pointoffset laterally in a first direction from the center point, and thesecond point offset laterally in a second direction from the centerpoint, the first and second directions substantially opposed to eachother, so that the first and second filament extend to a locationoutside the patient; providing tension on the first and second filamentsso that the anchoring member is firmly engaged with tissue adjacent theopening, one or more of the anchoring member and the filamentspreventing movement of the anchoring member with respect to the openingto the degree that an end of the anchoring member is within the opening;locking the anchoring member in place with respect to the tissue. 11.The method of claim 10, wherein the inserting step includes theanchoring member having a hemostatic valve and a guide wire extendingthrough the valve, and further comprising: monitoring the treatment ofthe tissue opening, and where an emergency is detected, applying amedical device over the guide wire to one or both of the tissue and theopening.
 12. A method of treating an opening in tissue, comprising:inserting through the opening a medical treatment device having ananchoring member having a concave inner surface configured to cover allof the opening, the medical treatment device having at least first andsecond filaments connected to the anchoring member and adapted to extendfrom the anchoring member to a position outside of the patient, thefirst filament having a first end attached to a first stem fixed to theinner surface of the anchoring member at a first point and extendingaway from the inner surface to a free second end, said second filamenthaving a third end attached to a second stem fixed to the inner surfaceof the anchoring member at a second point an extending away from theinner surface to a free fourth end, the first and second filament beingseparate from each other, the anchoring member having a center point,with the first point offset laterally in a first direction from thecenter point, and the second point offset laterally in a seconddirection from the center point, the first and second directionssubstantially opposed to each other, so that the first and secondfilament extend to a location outside the patient, wherein the insertingstep includes placing the anchoring member so that the first and secondstems both extend through the opening so that the stems limit movementof the anchoring member with respect to the opening; providing tensionon the first and second filaments so that the anchoring member is firmlyengaged with tissue adjacent the opening, one or more of the anchoringmember and the filaments preventing movement of the anchoring memberwith respect to the opening to the degree that an end of the anchoringmember is within the opening; locking the anchoring member in place withrespect to the tissue.